Dapagliflozin in Non Alcoholic Fatty Liver Disease Associated Cirrhosis and Its Role in Preventing Development of Chronic Kidney Disease.

Sponsor
Institute of Liver and Biliary Sciences, India
Study ID
NCT05849220
Status
Unknown

Conditions

  • NAFLD Cirrhosis

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Dapagliflozin
  • Standard of Care — OTHER
    Standard of Care

Study Details

The role of Dapagliflozin in the improvement in CKD in both diabetic and non-diabetic patients has been evaluated in the past. SGLT2i have also been found to be beneficial in NAFLD patients in improving the liver function parameters. It is also known that cirrhotic patients are at a higher risk of developing CKD at 1 year when compared to non cirrhotics. With this study we aim to study the role Dapagliflozin in cirrhotic patients in reducing the development of CKD, its impact on cirrhotic cardiomyopathy and its role in improvement of metabolic profile and liver related outcomes.

Key Dates

Start date
May 15, 2023
Status verified
Mar 2023
Primary completion
Mar 30, 2024
Completion
Mar 30, 2024

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin+Standard of Care
    Dapagliflozin
  • Active Comparator: Standard of Care
    Standard of Care

Primary Outcome Measure

Number of participants developing Chronic Kidney Disease at 1 yr defined as per KDIGO guidelines. [ Time Frame: 1 year ]

Central Contacts